Model Number TJF-260V |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus inspected the device at the service department of olympus (b)(4) and found that gaps of adhesive of distal end and dirt inside the lens at the distal end.There was no report of patient injury associated with this event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from olympus korea, the reported phenomenon could have been attributed to air leak from the instrument channel.The leak of the instrument channel could have occurred due to excessive force applied to the instrument channel by inserting the endo-therapy accessory with the tip opened or forcibly inserting it while angulated.
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Search Alerts/Recalls
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